A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Official Title

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Summary:

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumour assessments and safety laboratory values.

Trial Description

Primary Outcome:

  • Evaluate antitumour activity of niraparib
Secondary Outcome:
  • Evaluate durability of anti-cancer activity (i.e. time from first response, CR or PR until disease progression).
  • Evaluate antitumour activity of niraparib in HRD+ and gBRCAmut
  • Disease Control Rate (DCR)
  • Progression Free Survival
  • Overall Survival
  • Evaluate the safety and tolerability of niraparib in ovarian cancer patients (Review of adverse events, concomitant medications, physical exams, electrocardiograms (ECGs), and safety lab values.)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society